MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134702

Device Problems Entrapment of Device (1212); Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981); Mechanical Jam (2983); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

On 30-jan-2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with thermocool® smart touch® sf uni-directional navigation catheter which encountered electrode damage causing the catheter¿s deflection to become stuck and entrapped in the patient.It was reported by the bwi representative that during the pvc ablation, the thermocool® smart touch® sf uni-directional navigation catheter seems to have gotten stuck in the patient due to a "kink by the proximal electrode".This issue affected the deflection capabilities of the catheter resulting in the physician being unable to straighten it out.The physician continued maneuvering the catheter to remove it and upon removal, the catheter was replaced, and the procedure continued.There was no patient consequence.Additional information was received indicating the catheter was not stuck in a fully deflected position.The knob was still able to be pushed down.The failure was found during the procedure and resulted in difficulty removing the catheter.There was no damage to the distal end of the catheter that i noticed.The sheath being used was a large curve abbott agilis sheath 8.5 fr inner diameter.The damage did not result in exposed wires or in damaged or sharp rings.There was no patient consequence involved and medical intervention was not needed.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 27-feb-2023, an internal review of the reported event led to reassessment and recoding of the reported issues.It was initially reported that the device encountered electrode damage causing the catheter¿s deflection to become stuck.Both of these issues were incorrectly assessed as mdr reportable because information that was available clarified that the catheter was not stuck in a fully deflected position and there was no electrode damage.There was only a kink that did not result in exposed wires or in damaged or sharp rings.As such, the reported deflection issue and bent in the shaft (kink) are not considered to be mdr reportable therefore the following coding corrections have been processed: h6.Medical device problem code has been updated from mechanical jam (a0506) to positioning problem (a1502).H6.Medical device problem code has been updated from material protrusion/extrusion (a0411) to material twisted / bent (a040609).

Manufacturer Narrative

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with thermocool® smart touch® sf uni-directional navigation catheter wherein the device became entrapped in the patient.It was reported by the bwi representative that during the pvc ablation, the thermocool® smart touch® sf uni-directional navigation catheter seems to have gotten stuck in the patient due to a "kink by the proximal electrode".This issue affected the deflection capabilities of the catheter resulting in the physician being unable to straighten it out.The physician continued maneuvering the catheter to remove it and upon removal, the catheter was replaced, and the procedure continued.There was no patient consequence.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection, deflection test, tilt test, and functional test of the returned device were performed following bwi procedures.Visual analysis revealed a bent in the shaft next to ring #4, no other damage or anomalies on the device were seen.A deflection test was performed, and the curve was deflecting within specifications.A dimensional test was performed, and outer diameters of the device were found within specifications.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The bent tip issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the kink (bent).Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer's reported issues of deflection problems and device entrapment.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16304461
• MDR Text Key: 308863305
• Report Number: 2029046-2023-00227
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30922421L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LARGE CURVE ABBOTT AGILIS SHEATH 8.5 FR.; THMCL SMTCH SF UNID, TC, F.